BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1211346 · Received October 28, 2008

    Report

    Report Number
    1034569-2008-00519
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 23, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIMITATION IN THE PACKAGE INSERT STATES THAT PASSIVELY ADMINISTERED ANTI D MAY FAIL TO REACT BY CAPTURE-R READY-SCREEN, EVEN THOUGH THE ANTIBODIES ARE DETECTED BY AN ALTERNATIVE TECHNIQUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WITH THE 2 CELL SCREEN SCREEN ASSAY ON GALILEO, ON A PATIENT WHO HAD RECEIVED RHOGAM. CAPTURE-R READY SCREEN WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X259

    Patients

    Seq Age Sex Outcome Treatment
    1